Europe Falls Behind in Clinical Trials Compared to US and China

Europe’s Decline in Pharmaceutical Clinical Trials Poses Threat to Competitiveness

A new report reveals a concerning trend in Europe’s shrinking role in global pharmaceutical clinical trials. Over the past decade, Europe’s share of global clinical trials has drastically fallen, raising alarms about the region’s future competitiveness in the pharmaceutical industry. This Europe pharmaceutical trials decline could have significant implications for global health.

According to a study by IQVIA, commissioned by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and Vaccines Europe, Europe’s market share of global clinical trials has plummeted from 22% in 2013 to just 12% in 2023. In contrast, Asia, particularly China, has seen substantial growth, with its share skyrocketing from 8% in 2013 to 29% in 2023. This shift reflects a broader global trend in which more clinical trials are being conducted in Asia, challenging Europe’s long-standing dominance in pharmaceutical research.

Declining Phase 1 and Pediatric Trials in Europe

One of the key reasons for Europe’s declining share is the notable reduction in phase 1 trials, which are essential for assessing the safety and dosage of new drugs. This decline has serious implications for future clinical research, as phase 1 trials provide the foundation for later stages of drug development. With fewer phase 1 trials, Europe faces a potential shortage of critical data needed for advancing drug candidates, limiting the region’s capacity to innovate and compete globally.

In addition to the decline in phase 1 trials, Europe has also seen a significant reduction in pediatric trials. The number of pediatric trials conducted in Europe dropped from 142 in 2012 to just 75 in 2023, while globally, pediatric trials grew by 4% each year. Despite this downward trend, some European countries, including Greece, Portugal, and Slovakia, have bucked the trend by maintaining or increasing their clinical trial activities. Spain, in particular, has shown a strong upward trajectory, with clinical trial investment more than doubling from €479 million in 2012 to €834 million in 2022, positioning it as a leader in clinical trial starts.

Challenges and Factors Contributing to Europe’s Decline

Several factors contribute to Europe’s declining role in global clinical trials. Increased clinical trial capacity in third countries, especially in Asia, is one of the primary reasons. As countries like China expand their clinical trial infrastructure and capabilities, they have become more attractive to pharmaceutical companies looking for more cost-effective or efficient trial sites. The COVID-19 pandemic also disrupted health systems worldwide, slowing clinical trial progress in Europe. Additionally, the new EU regulations, introduced with the aim of creating a more attractive research environment, have yet to yield the desired improvements. Despite the EU Clinical Trial Regulation coming into force in January 2023 to streamline processes, Europe has not seen a significant uptick in its share of global trials.

Longer Timelines and Recruitment Issues

The report also highlights that clinical trials in Europe, particularly in areas such as oncology, rare diseases, and infectious diseases, take longer than in other regions, particularly the US. A key issue driving these delays is the slow patient recruitment process in Europe, which exacerbates the region’s difficulties in maintaining its competitive edge in clinical research. The prolonged timelines not only hinder the region’s ability to keep pace with global competitors but also deter investment from pharmaceutical companies looking to launch trials quickly and efficiently.

Conclusion: Europe’s Need for Reform

Europe’s shrinking share of global clinical trials signals a critical challenge for the region’s pharmaceutical industry. While some countries, like Spain, have made strides in attracting clinical trials, the overall trend points to the urgent need for reform. Europe must address the various barriers—such as slow patient recruitment, regulatory complexities, and the increasing shift of clinical trials to Asia—if it hopes to remain a competitive player in global pharmaceutical research. If not, the region risks falling further behind, as countries like China continue to dominate the clinical trial landscape.